CA2197578A1 - Encapsulated biological indicator - Google Patents
Encapsulated biological indicatorInfo
- Publication number
- CA2197578A1 CA2197578A1 CA002197578A CA2197578A CA2197578A1 CA 2197578 A1 CA2197578 A1 CA 2197578A1 CA 002197578 A CA002197578 A CA 002197578A CA 2197578 A CA2197578 A CA 2197578A CA 2197578 A1 CA2197578 A1 CA 2197578A1
- Authority
- CA
- Canada
- Prior art keywords
- membrane
- microbial
- microorganisms
- set forth
- reference microorganisms
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/8215—Microorganisms
- Y10S435/822—Microorganisms using bacteria or actinomycetales
- Y10S435/832—Bacillus
Abstract
Reference microorganisms are sealed into an interior cavity of a microporous membrane (14, 20). In one embodiment, the reference microbes are inoculated on element (12) which is sealed in a microporous envelope (14) (figure 1). In another embodiment, the reference microbes (22) are loaded into an interior bore or cavity of a microporous plastic tube or envelope (20) (figure 3). The microporous membrane and the reference microbes, such as spores, are immersed concurrently with items to be microbially decontaminated separately into an anti-microbial fluid. The microporous membrane is constructed of a material which is sufficiently resistant to temperature, water, strong oxidants, and other anti-microbial agents or processes used for microbial decontamination or sterilization that retains its integrity during the immersion in any common steam, gas, or liquid microbial decontamination or sterilization fluid or system. The micropores are sufficiently small that the reference microbes are entrapped, yet sufficiently open that anti-microbial steam, gas, or liquid are passed into the interior for direct contact with the reference microbes. After the microbial decontamination process, the microporous membrane and the contained reference microbes are immersed in a culture medium (40) and monitored to determine whether any of the reference microbes remain alive and commence growing.
Description
~19757~
096/061~ PCT~S9Sl10443 EUCAP8ULAT~D BI~nOGI~T INDICATOR
.
~açk~rQnn~ Or the Invention The present invention relates to the art of biological indicators. It ~inds particular application in conjunction with spore inoculated elements used for indicating the completeness of a sterilization process and will be described with particular reference thereto.
Heretofore, various sterilization indicating systems have been provided. The systems generally ;nrlll~ad an element, e.g. a pad or strip, which was inoculated with a spore or other microorganism. In some systems, the pad was mounted in a container and connected with the container exterior by a tortuous path or otherwise. The container was ~i~posed such that during a gas or high ~I~S~L~ steam sterilization process, the pad was subject to substantially the same sterilizing conditions by gas or high pressure steam that penetrates the tortuous path as the articles being sterilized. At the end of the sterilizing operation, the tortuous path was closed, a glass ampule containing a culture medium was fractured, and the pad and culture medium were brought together. After an ~p~L~pLiate incubation period, the culture medium was PY~m;npd for evidence of growth of the inoculated microorganisms. A
lack of microorganism growth was indicative of sterilization and growth of the microorganisms was indicative that the sterilization process was not complete.
See, for example, U.S. Patent Nos. 4,461,837 and 4,743,537.
.
, J !
096/061~ PCT~S9Sl10443 EUCAP8ULAT~D BI~nOGI~T INDICATOR
.
~açk~rQnn~ Or the Invention The present invention relates to the art of biological indicators. It ~inds particular application in conjunction with spore inoculated elements used for indicating the completeness of a sterilization process and will be described with particular reference thereto.
Heretofore, various sterilization indicating systems have been provided. The systems generally ;nrlll~ad an element, e.g. a pad or strip, which was inoculated with a spore or other microorganism. In some systems, the pad was mounted in a container and connected with the container exterior by a tortuous path or otherwise. The container was ~i~posed such that during a gas or high ~I~S~L~ steam sterilization process, the pad was subject to substantially the same sterilizing conditions by gas or high pressure steam that penetrates the tortuous path as the articles being sterilized. At the end of the sterilizing operation, the tortuous path was closed, a glass ampule containing a culture medium was fractured, and the pad and culture medium were brought together. After an ~p~L~pLiate incubation period, the culture medium was PY~m;npd for evidence of growth of the inoculated microorganisms. A
lack of microorganism growth was indicative of sterilization and growth of the microorganisms was indicative that the sterilization process was not complete.
See, for example, U.S. Patent Nos. 4,461,837 and 4,743,537.
.
, J !
2 1 9 7 5 7 8 PCT~S95/1044 ~
.-: .;, A disàdvantage of the prior art sterilization indicating systems was that the element containing the spores or other microorganisms was often times a spore strip pad. The spores, when contacted by sterilant or disinfectant mediums, could potentially be ~iclodg~
These problems have been addressed by placing the inoculated element in an envelope of sorts, the envelope being cu..~LLu~Led from a semi-porous or non-porous material, and usually from paper. The paper, however, was easily dissolved when using a liquid sterilant or disinfectant or made it very difficult to transfer aseptically to culture medium, thus requiring that the strip be removed from the envelope prior to use, making it very difficult to transfer the strip aseptically to the culture medium. If the spore containing element or spore strip was removed from the envelope, however, the potential problem such as the spores being washed off of the strip may again be encountered.
The present invention provides a new and i ~ ov~d spore containing element which is suitable for use in steam, gas, or liquid sterilant systems, yet uv~, c the above-referenced problems.
Summarv of the Invention In accordance with the present invention, a method of insuring completeness of a decontamination process for eliminating microbial contamination is provided. Reference microorganisms and items to be decontaminated are immersed in an anti-microbial fluid.
The reference organisms are removed from the anti-microbial fluid and immersed in a culture medium. A det~rmin~tion is made whether any of the reference mi~LuuLU~nisms grow in the culture medium. The method is characterized by encapsulating the reference microorganisms in a hydrophilic mi~L U,UUL OUS enclosure having pores that are smaller than the microorganisms such that the reference microorganisms are trapped therein. The enclosure is sufficiently porous ~ W096/06184 21 9 75 7 8 PCT~S9~10443 ,3 to pas6 the anti-microbial fluid and the culture medium therethrough.
In accordance with another aspect of the present lnvention, a biological indicator is provided. The biological indicator is immersed in a flowing anti-microbial fluid along with items to be microbially decontaminated. The biological indicator has reference microorganisms that are subsequently introduced into a li~uid culture medium. The indicator is further characterized by a hydrophilic, microporous membrane within which the reference microorganisms are enclosed. The hydrophilic microporous membrane has pores that are sufficiently small that the reference microorganisms are trapped therein. Yet, the anti-microbial fluid and the liquid culture medium pass through the hydrophilic mi~L~pu~us membrane.
One advantage of the present invention is that the subject ~n~ApsulAted biological indicator eliminates the potential for spores to be washed off of a spore strip or other spore carrying element.
Another advantage of the present invention is the elimination of the potential for operator contamination because the encapsulated biological indicator retains the spores in an inAcc~csible~ interior cavity.
Yet another advantage of the present invention is that the ~nrApslllAted biological indicator is suitable for use with _ ~ially available gas, steam, and liquid biological indicator systems.
Still further advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred ~mho~;m c.
Irief DescriPtion of th- Drawin~s The invention may take form in various Ls and arrangements of - ~ts, and in various steps and arrangements of steps. The drawings are only for purposes ~096/06184 PCT~Sg~1044i ~
2~97~7~ , .
~ - 4 -of illustrating a preferred ~mho~ L and are not to be construed as limiting the invention.
FIGURE 1 is an illustration of a microorganism inoculated strip in a microporous membrane, particularly an 5 envelope; b FIGURE 2 is an alternate ~o~i L in which spores are extruded in an interior channel of mi~l U~UL U~S
tubing; and, FIGURE 3 illustrates a biological indicator system. ' ~etailed ~escriPtion of the Preferred Embodiment With reference to FIGURE 1, a microorganism-inoculated, biological indicator 10 includes a spore inoculated element or strip 12. The spore inoculated element is wrapped or encapsulated in a microporous, hydrophilic membrane 14. The inoculated indicator element may be a spore strip, or any other suitable element inoculated with spores suitable for evaluating the completeness of a given sterilization system. Alternately, the spores may be charged directly to the interior region of the encapsulating membrane 14 without aid of any kind of carrying element such that the membrane carries the spores.
Typically, the microorganisms or spores are bacteria spores that have a resistance selected in a uu.d~nce with the sterilizing, disinfecting, or other microbial decontamination procedure to be monitored. That is, microorganisms are selected which will be killed under more dr--n~ng decontamination conditions than bacteria or microorganisms typically on the items to be decontaminated.
Further, the mi~LouLu~nisms are also selected to have a relatively fast growth rate or short r~LuduuLion time in a liguid culture medium. Various microbe inoculations and ~uLr. ~ ing culture medium combinations are well-known in the art.
The microporous membrane ~nc~rs~ nt may be comprised of any suitable natural or synthetic copolymer _ _ ~ WO96/~6184 ~ ~5 7~ r~ J~IU443 ;- 5 material which is mi~LupùIuùs in nature, and preferably which is hydrophilic. r _l~ry of such materials are lll~lnsir membranes and organic polymer membranes inclllAinrJ simple hYd10U~LbUII membranes, such as polyethylene and polypropylene, as well as more polar structures, such as polyamide -- dnes which inrll-~Pc nylon, acrylic copolymers, polysulfone, polyethersulfone, ethylene vinyl alcohol, and polyacrylonitrile. The membrane Pnr~rcnlAnt materlal is resistant to degradation by the liquid microbial decontamination solutions and remains porous. The Pnr~rs~ nt must also be resistant to strong oxidants such as peracetic acid, peroxides, hypochlorites, chlorine gas or ions, ethylene oxide gas, and the like, and be heat insensitive at higher or sterilization temperatures.
The membrane D~r~rs~llAnt material has micropores of a A i; ' slightly less than that of the spores contained within the interior region or cavity of the ~r~rslll~ting membrane such that the spores cannot escape the interior of the membrane. Due to the porous nature of the encapsulating membrane, the decontamination medium, whetber gas, steam, or liquid, easily flows to the interior of the membrane and contacts the spores or microorganisms.
In this regard, it is i LdnL when using a liquid sterilant that the membrane be hydrophilic in nature so that the liquid sterilant solution wets the membrane and is transported through the pore structure of the membrane to the interior region or cavity thereof. Of course, if a membrane material is EelDrtDA which i5 not normally hydrophilic in nature, the material may be treated in a manner known to those skilled in the art of using such materials to render the membrane hydrophilic.
The Pnr~rs~ ting membrane may be in the form of an envelope cont~ininrJ a spore strip or other inoculated element, such as a disk, of the kind known to those skilled in the art. In this instance, the membrane would be formed or yLodu~ed and the inoculated element subse~u~,lLly added WO96/06184 21~ ~ - i 8 PCT~S95/1044 ~
to the membrane envelope. The term "envelope" as used herein inrln~7~s any membrane configuration, such as pillows, tubes, and the like, which lends itself to the subsequent addition of a spore-inoculated element and which can then be sealed to retain the inoculated element therein.
With reference to FIG7JRE 2, the membrane may also be in the form of an extruded membrane tube 20 having spores 22 r7.icposP~7 in the interior thereof. In this type of indicator, the extrusion of the membrane and deposition or charging of spores to the interior of the membrane may be a _ ~li Ch~d in a singular process. Conversely, the spores may be charged to the interior of the extruded membrane subsequent to extrusion. The extruded membrane containing the spores may then be sealed, for instance by heat sealing 24, to retain the spores therein. Exemplary of an extruded membrane would be a membrane in the form of a capillary tube of porous polyethylene, polypropylene, nylon, polysulfone, polyethersulfone, acrylic copolymers, ethylene vinyl alcohol, polyacrylonitrile, polycarbonate, polyphthalate carbonate, polytetrafluoroethylene, cellulosics, or the like.
The spores may be disposed in the membrane in a dry state, or may be ~7.;CPOF~d in the membrane in a suitable carrier medium. A suitable carrier medium will be any medium which does not interfere with or is non-reactive with the microbial decontaminant, which does not adversely affect or degrade the ~nr;7rs~lating membrane, and which is compatible with the culture media which the spores may eventually contact, e.g. it must not interfere with the growth of spores which may remain alive. In this latter case, interference with the culture media may result in a false negative, leading the user to believe incorrectly that the microbial decontamination system is functioning properly. Alternatively, the culture media may, upon contact with the membrane ~77r;7rs171;7ted spore-inoculated O WO96/06184 2 1 9 7 5 7 8 PCT~
, . .., ~ . .
element, indicate viability of the spore sample by a color change of the media.
With reference to FIGURE 3, it is contemplated that the present invention may be easily adapted for use in J 5 known biological indicator systems. For instance, in systems which employ a vial-type device 30, the subject P~rArslllAted indicator 10 may be placed in a position such that it is in the flow path of the microbial decontaminant via apertures 32 in a cap 34. Apertures 32 may be large 10 holes or slots, slits, or the like. After the decontamination cycle, the cap is depressed, or the cap may be screwed down, to sever a member 36 with a cutter 38 and release the ~n~Aps~lAted spore inoculated indicator 10 into a culture media 40, which may be a self-contained media 15 vial. The cap in the depressed or closed position seals the culture media from the environment. Alternately, the spore strip can be transferred to a remote culture media container. In either instance, because any living spores are held within the ~nrArslllAting membrane 14, 20, there is 20 no chance for contamination of the spores during transition to the culture media. A biological indicator system of the type which directly deposits the spore-carrying element into the culture media is taught and illustrated in U.S.
Patent No. 4,885,253. The subject encapsulated biological 25 indicator is suitable as taught herein for use in that system. others systems wherein the present indicator can be used will be known to those skilled in the art.
! "' i~ '?~
.-: .;, A disàdvantage of the prior art sterilization indicating systems was that the element containing the spores or other microorganisms was often times a spore strip pad. The spores, when contacted by sterilant or disinfectant mediums, could potentially be ~iclodg~
These problems have been addressed by placing the inoculated element in an envelope of sorts, the envelope being cu..~LLu~Led from a semi-porous or non-porous material, and usually from paper. The paper, however, was easily dissolved when using a liquid sterilant or disinfectant or made it very difficult to transfer aseptically to culture medium, thus requiring that the strip be removed from the envelope prior to use, making it very difficult to transfer the strip aseptically to the culture medium. If the spore containing element or spore strip was removed from the envelope, however, the potential problem such as the spores being washed off of the strip may again be encountered.
The present invention provides a new and i ~ ov~d spore containing element which is suitable for use in steam, gas, or liquid sterilant systems, yet uv~, c the above-referenced problems.
Summarv of the Invention In accordance with the present invention, a method of insuring completeness of a decontamination process for eliminating microbial contamination is provided. Reference microorganisms and items to be decontaminated are immersed in an anti-microbial fluid.
The reference organisms are removed from the anti-microbial fluid and immersed in a culture medium. A det~rmin~tion is made whether any of the reference mi~LuuLU~nisms grow in the culture medium. The method is characterized by encapsulating the reference microorganisms in a hydrophilic mi~L U,UUL OUS enclosure having pores that are smaller than the microorganisms such that the reference microorganisms are trapped therein. The enclosure is sufficiently porous ~ W096/06184 21 9 75 7 8 PCT~S9~10443 ,3 to pas6 the anti-microbial fluid and the culture medium therethrough.
In accordance with another aspect of the present lnvention, a biological indicator is provided. The biological indicator is immersed in a flowing anti-microbial fluid along with items to be microbially decontaminated. The biological indicator has reference microorganisms that are subsequently introduced into a li~uid culture medium. The indicator is further characterized by a hydrophilic, microporous membrane within which the reference microorganisms are enclosed. The hydrophilic microporous membrane has pores that are sufficiently small that the reference microorganisms are trapped therein. Yet, the anti-microbial fluid and the liquid culture medium pass through the hydrophilic mi~L~pu~us membrane.
One advantage of the present invention is that the subject ~n~ApsulAted biological indicator eliminates the potential for spores to be washed off of a spore strip or other spore carrying element.
Another advantage of the present invention is the elimination of the potential for operator contamination because the encapsulated biological indicator retains the spores in an inAcc~csible~ interior cavity.
Yet another advantage of the present invention is that the ~nrApslllAted biological indicator is suitable for use with _ ~ially available gas, steam, and liquid biological indicator systems.
Still further advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred ~mho~;m c.
Irief DescriPtion of th- Drawin~s The invention may take form in various Ls and arrangements of - ~ts, and in various steps and arrangements of steps. The drawings are only for purposes ~096/06184 PCT~Sg~1044i ~
2~97~7~ , .
~ - 4 -of illustrating a preferred ~mho~ L and are not to be construed as limiting the invention.
FIGURE 1 is an illustration of a microorganism inoculated strip in a microporous membrane, particularly an 5 envelope; b FIGURE 2 is an alternate ~o~i L in which spores are extruded in an interior channel of mi~l U~UL U~S
tubing; and, FIGURE 3 illustrates a biological indicator system. ' ~etailed ~escriPtion of the Preferred Embodiment With reference to FIGURE 1, a microorganism-inoculated, biological indicator 10 includes a spore inoculated element or strip 12. The spore inoculated element is wrapped or encapsulated in a microporous, hydrophilic membrane 14. The inoculated indicator element may be a spore strip, or any other suitable element inoculated with spores suitable for evaluating the completeness of a given sterilization system. Alternately, the spores may be charged directly to the interior region of the encapsulating membrane 14 without aid of any kind of carrying element such that the membrane carries the spores.
Typically, the microorganisms or spores are bacteria spores that have a resistance selected in a uu.d~nce with the sterilizing, disinfecting, or other microbial decontamination procedure to be monitored. That is, microorganisms are selected which will be killed under more dr--n~ng decontamination conditions than bacteria or microorganisms typically on the items to be decontaminated.
Further, the mi~LouLu~nisms are also selected to have a relatively fast growth rate or short r~LuduuLion time in a liguid culture medium. Various microbe inoculations and ~uLr. ~ ing culture medium combinations are well-known in the art.
The microporous membrane ~nc~rs~ nt may be comprised of any suitable natural or synthetic copolymer _ _ ~ WO96/~6184 ~ ~5 7~ r~ J~IU443 ;- 5 material which is mi~LupùIuùs in nature, and preferably which is hydrophilic. r _l~ry of such materials are lll~lnsir membranes and organic polymer membranes inclllAinrJ simple hYd10U~LbUII membranes, such as polyethylene and polypropylene, as well as more polar structures, such as polyamide -- dnes which inrll-~Pc nylon, acrylic copolymers, polysulfone, polyethersulfone, ethylene vinyl alcohol, and polyacrylonitrile. The membrane Pnr~rcnlAnt materlal is resistant to degradation by the liquid microbial decontamination solutions and remains porous. The Pnr~rs~ nt must also be resistant to strong oxidants such as peracetic acid, peroxides, hypochlorites, chlorine gas or ions, ethylene oxide gas, and the like, and be heat insensitive at higher or sterilization temperatures.
The membrane D~r~rs~llAnt material has micropores of a A i; ' slightly less than that of the spores contained within the interior region or cavity of the ~r~rslll~ting membrane such that the spores cannot escape the interior of the membrane. Due to the porous nature of the encapsulating membrane, the decontamination medium, whetber gas, steam, or liquid, easily flows to the interior of the membrane and contacts the spores or microorganisms.
In this regard, it is i LdnL when using a liquid sterilant that the membrane be hydrophilic in nature so that the liquid sterilant solution wets the membrane and is transported through the pore structure of the membrane to the interior region or cavity thereof. Of course, if a membrane material is EelDrtDA which i5 not normally hydrophilic in nature, the material may be treated in a manner known to those skilled in the art of using such materials to render the membrane hydrophilic.
The Pnr~rs~ ting membrane may be in the form of an envelope cont~ininrJ a spore strip or other inoculated element, such as a disk, of the kind known to those skilled in the art. In this instance, the membrane would be formed or yLodu~ed and the inoculated element subse~u~,lLly added WO96/06184 21~ ~ - i 8 PCT~S95/1044 ~
to the membrane envelope. The term "envelope" as used herein inrln~7~s any membrane configuration, such as pillows, tubes, and the like, which lends itself to the subsequent addition of a spore-inoculated element and which can then be sealed to retain the inoculated element therein.
With reference to FIG7JRE 2, the membrane may also be in the form of an extruded membrane tube 20 having spores 22 r7.icposP~7 in the interior thereof. In this type of indicator, the extrusion of the membrane and deposition or charging of spores to the interior of the membrane may be a _ ~li Ch~d in a singular process. Conversely, the spores may be charged to the interior of the extruded membrane subsequent to extrusion. The extruded membrane containing the spores may then be sealed, for instance by heat sealing 24, to retain the spores therein. Exemplary of an extruded membrane would be a membrane in the form of a capillary tube of porous polyethylene, polypropylene, nylon, polysulfone, polyethersulfone, acrylic copolymers, ethylene vinyl alcohol, polyacrylonitrile, polycarbonate, polyphthalate carbonate, polytetrafluoroethylene, cellulosics, or the like.
The spores may be disposed in the membrane in a dry state, or may be ~7.;CPOF~d in the membrane in a suitable carrier medium. A suitable carrier medium will be any medium which does not interfere with or is non-reactive with the microbial decontaminant, which does not adversely affect or degrade the ~nr;7rs~lating membrane, and which is compatible with the culture media which the spores may eventually contact, e.g. it must not interfere with the growth of spores which may remain alive. In this latter case, interference with the culture media may result in a false negative, leading the user to believe incorrectly that the microbial decontamination system is functioning properly. Alternatively, the culture media may, upon contact with the membrane ~77r;7rs171;7ted spore-inoculated O WO96/06184 2 1 9 7 5 7 8 PCT~
, . .., ~ . .
element, indicate viability of the spore sample by a color change of the media.
With reference to FIGURE 3, it is contemplated that the present invention may be easily adapted for use in J 5 known biological indicator systems. For instance, in systems which employ a vial-type device 30, the subject P~rArslllAted indicator 10 may be placed in a position such that it is in the flow path of the microbial decontaminant via apertures 32 in a cap 34. Apertures 32 may be large 10 holes or slots, slits, or the like. After the decontamination cycle, the cap is depressed, or the cap may be screwed down, to sever a member 36 with a cutter 38 and release the ~n~Aps~lAted spore inoculated indicator 10 into a culture media 40, which may be a self-contained media 15 vial. The cap in the depressed or closed position seals the culture media from the environment. Alternately, the spore strip can be transferred to a remote culture media container. In either instance, because any living spores are held within the ~nrArslllAting membrane 14, 20, there is 20 no chance for contamination of the spores during transition to the culture media. A biological indicator system of the type which directly deposits the spore-carrying element into the culture media is taught and illustrated in U.S.
Patent No. 4,885,253. The subject encapsulated biological 25 indicator is suitable as taught herein for use in that system. others systems wherein the present indicator can be used will be known to those skilled in the art.
! "' i~ '?~
Claims (10)
1. A method of assuring completeness of a decontamination process for eliminating microbial contamination, in which reference microorganisms and items to be decontaminated are immersed in the anti-microbial fluid, the reference microorganisms are removed from the anti-microbial fluid and immersed in a culture medium and a determination is made whether any of the reference microorganisms grow in the culture medium, characterized by:
encapsulating the reference microorganisms in a hydrophilic microporous enclosure having pores that are smaller than the reference microorganisms such that the reference microorganisms are trapped therein, the enclosure being sufficiently porous to pass anti-microbial fluids and the culture medium therethrough;
immersing the reference microorganisms in the culture medium while the microorganisms are still encapsulated within the hydrophilic microporous enclosure.
encapsulating the reference microorganisms in a hydrophilic microporous enclosure having pores that are smaller than the reference microorganisms such that the reference microorganisms are trapped therein, the enclosure being sufficiently porous to pass anti-microbial fluids and the culture medium therethrough;
immersing the reference microorganisms in the culture medium while the microorganisms are still encapsulated within the hydrophilic microporous enclosure.
2. The method as set forth in preceding claim 1, wherein the anti-microbial fluid includes a strong oxidant, and further characterized by the hydrophilic microporous enclosure being sufficiently resistant to anti-microbial fluids and strong oxidants that the reference microorganisms are not released therefrom.
3. The method as set forth in either of preceding claims 1 or 2 further characterized by the encapsulating step including:
inoculating a porous element with the reference microorganisms;
after inoculating the porous element, wrapping the microorganism-inoculated element in the hydrophilic microporous membrane.
inoculating a porous element with the reference microorganisms;
after inoculating the porous element, wrapping the microorganism-inoculated element in the hydrophilic microporous membrane.
4. The method as set forth in either of preceding claims 1 or 2 further characterized by the hydrophilic microporous enclosure being a microporous plastic tube with a hollow interior and wherein the encapsulating step includes loading the microorganisms into the hollow interior of the tube, and sealing ends of the tube.
5. The method as set forth in any of preceding claims 1 through 4 further characterized by the enclosure being constructed from a microporous polyethylene, polypropylene, acrylic copolymers, polysulfone, polyethersulfone, ethylene vinyl alcohol, polyacrylonitrile, polycarbonate, polyphthalate carbonate, nylon, or cellulosics.
6. A biological indicator which is immersed in an anti-microbial fiuid along with items to be microbially decontaminated and which holds reference microorganisms that are subsequently introduced into a liquid culture medium, characterized by:
a hydrophilic microporous membrane in which the reference microorganisms are enclosed, the hydrophilic microporous membrane having pores which (1) are sufficiently small that the reference microorganisms are trapped within the hydrophilic, microporous membrane and (2) pass the anti-microbial fluid and the liquid culture medlum through the hydrophilic microporous membrane.
a hydrophilic microporous membrane in which the reference microorganisms are enclosed, the hydrophilic microporous membrane having pores which (1) are sufficiently small that the reference microorganisms are trapped within the hydrophilic, microporous membrane and (2) pass the anti-microbial fluid and the liquid culture medlum through the hydrophilic microporous membrane.
7. The biological indicator as set forth in preceding claim 6 further characterized by the spores being on a carrier medium enclosed within the membrane.
8. The biological indicator as set forth in either of preceding claims 6 or 7 further characterized by the membrane being in the form of an envelope.
9. The biological indicator as set forth in either of preceding claims 6 or 7 further characterized by the membrane being in the form of an extruded tube, the ends of the tube being sealed.
10. The biological indicator as set forth in any of preceding claims 6 through 9 further characterized by the membrane being selected from the group consisting of polyethylene, polypropylene, acrylic copolymers, polysulfone, polyethersulfone, ethylene vinyl alcohol, polyacrylonitrile, polycarbonate, polyphthalate carbonate, nylon, or cellulosics.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/292,737 | 1994-08-18 | ||
| US08/292,737 US5516648A (en) | 1994-08-18 | 1994-08-18 | Encapsulated biological indicator |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2197578A1 true CA2197578A1 (en) | 1997-03-19 |
Family
ID=23125983
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002197578A Abandoned CA2197578A1 (en) | 1994-08-18 | 1995-08-16 | Encapsulated biological indicator |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US5516648A (en) |
| EP (1) | EP0777745A1 (en) |
| JP (1) | JPH09510625A (en) |
| AU (1) | AU689310B2 (en) |
| CA (1) | CA2197578A1 (en) |
| MX (1) | MX9701139A (en) |
| WO (1) | WO1996006184A1 (en) |
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| JPH11510051A (en) * | 1995-07-28 | 1999-09-07 | ミネソタ マイニング アンド マニュファクチャリング カンパニー | Multi-zone sterilization indicator |
| JP2000501661A (en) * | 1995-12-07 | 2000-02-15 | ミネソタ マイニング アンド マニュファクチャリング カンパニー | Ink jet printable microporous film |
| US5736355A (en) * | 1996-05-13 | 1998-04-07 | Steris Corporation | Self contained biological indicator |
| US6653096B1 (en) | 1996-07-29 | 2003-11-25 | Process Challenge Devices | Process challenge device and method |
| US5928948A (en) * | 1997-03-10 | 1999-07-27 | Steris Corporation | Method for the assessment and validation of cleaning processes |
| GB9706902D0 (en) * | 1997-04-04 | 1997-05-21 | Browne Albert Ltd | Test device and method |
| US6238623B1 (en) | 1997-05-21 | 2001-05-29 | 3M Innovative Properties Company | Labels and tracking systems for sterilization procedures |
| US6063631A (en) * | 1997-05-21 | 2000-05-16 | 3M Innovative Properties Company | Sterilization indicator |
| US6287518B1 (en) | 1997-06-25 | 2001-09-11 | 3M Innovative Properties Company | Sterilization monitors |
| US5866356A (en) * | 1997-10-20 | 1999-02-02 | Minnesota Mining And Manufacturing Company | Protective housing for biological indicator for testing the effectiveness of a sterilization procedure |
| US6355448B1 (en) * | 1998-06-02 | 2002-03-12 | 3M Innovative Properties Company | Sterilization indicator with chemically stabilized enzyme |
| US7045343B2 (en) * | 1998-06-02 | 2006-05-16 | 3M Innovative Properties Company | Sterilization indicator test packs |
| US6352837B1 (en) | 1999-02-22 | 2002-03-05 | 3M Innovative Properties Company | Rapid readout sterilization indicator for liquid peracetic acid sterilization procedures |
| US6942989B2 (en) | 1999-05-03 | 2005-09-13 | Icf Technologies, Inc. | Methods, compositions and kits for biological indicator of sterilization |
| US7326562B2 (en) * | 1999-05-03 | 2008-02-05 | Icf Technologies, Inc. | Biological indicator system to detect effectiveness of sterilization |
| US20040106167A1 (en) * | 1999-05-03 | 2004-06-03 | Icf Technologies, Inc. | Methods for evaluating sterilization procedures using a biological indicator |
| WO2001013964A1 (en) * | 1999-08-24 | 2001-03-01 | Process Challenge Devices | Device to assess efficacy of sterilization procedure |
| US6528277B1 (en) * | 1999-11-22 | 2003-03-04 | 3M Innovative Properties Company | Indicator systems for determination of sterilization |
| DE19962148A1 (en) * | 1999-12-22 | 2001-07-26 | Heralt Schoene | Detecting cleaning and/or disinfection of surfaces or objects used in the health care and pharmaceutical industries comprises using an applicator with a carrier |
| GB0002382D0 (en) * | 2000-02-03 | 2000-03-22 | Browne Albert Ltd | Sterilizer test device |
| US7090808B2 (en) * | 2001-07-09 | 2006-08-15 | Pharmaceutical Systems, Inc. | Apparatus for testing sterilization methods and materials |
| US6924139B2 (en) * | 2003-07-16 | 2005-08-02 | Steris Inc. | Self-contained biological indicator |
| US20080206801A1 (en) * | 2007-02-27 | 2008-08-28 | Steris Inc. | Biological indicator for use with vaporous microbial deactivating agents and method for making same |
| US8133164B2 (en) * | 2008-01-14 | 2012-03-13 | National Oilwell Varco L.P. | Transportable systems for treating drilling fluid |
| US8173388B2 (en) * | 2008-09-30 | 2012-05-08 | American Sterilizer Company | Self-contained biological indicator |
| EP2347007A2 (en) | 2008-10-17 | 2011-07-27 | 3M Innovative Properties Company | Biological sterilization indicator, system, and methods of using same |
| CH704312A1 (en) | 2011-01-05 | 2012-07-13 | Skan Ag | Bioindicator. |
| CN102151488A (en) * | 2011-03-04 | 2011-08-17 | 杭州泰林生物技术设备有限公司 | Grating filter membrane with sterilization indicating function |
| US10774362B2 (en) | 2013-12-23 | 2020-09-15 | Merck Patent Gmbh | Sample preparation unit and sample preparation device |
| CN106794462B (en) * | 2014-10-15 | 2019-12-20 | 默克专利股份有限公司 | Sample preparation container |
| US10907126B2 (en) | 2016-03-01 | 2021-02-02 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
| CN106267277B (en) * | 2016-09-28 | 2022-09-09 | 中国科学院苏州生物医学工程技术研究所 | Biological indicator detection device for monitoring sterilization effect of lumen instruments |
| US11242505B2 (en) | 2017-01-03 | 2022-02-08 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
| US11053534B2 (en) | 2017-06-30 | 2021-07-06 | Asp Global Manufacturing Gmbh | Systems and methods for confirming activation of biological indicators |
| EP3688183A1 (en) * | 2017-09-29 | 2020-08-05 | Meducomp GmbH | Device and method for the microbiological examination of washing machines |
| EP3461906A1 (en) * | 2017-09-29 | 2019-04-03 | Meducomp GmbH | Device and method for microbiological testing of washing machines |
| US11248250B2 (en) | 2017-12-01 | 2022-02-15 | Asp Global Manufacturing Gmb | Self-contained biological indicator |
| FR3088076B1 (en) * | 2018-11-05 | 2022-11-11 | Sterixene | BIO-INDICATOR OF DECONTAMINATION WITH HIGH FREQUENCY PULSED LIGHT |
| US11248251B2 (en) | 2018-11-28 | 2022-02-15 | American Sterilizer Company | Biological sterilization indicator |
| CA3197939A1 (en) | 2020-11-10 | 2022-05-19 | Nick N. Nguyen | Ampoule breaker for a biological indicator |
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| US4461837A (en) * | 1981-09-30 | 1984-07-24 | American Sterilizer Company | Contamination-free sterilization indicating system |
| US4918003A (en) * | 1985-08-30 | 1990-04-17 | Propper Manufacturing Company, Inc. | Biological test device for steam sterilizers |
| US4743537A (en) * | 1986-01-21 | 1988-05-10 | Castle Company | Biological indicator for sterilization processes |
| DE3705596A1 (en) * | 1986-11-24 | 1988-09-01 | Volker Barkey | Apparatus for detecting a disinfection process |
| US4937115A (en) * | 1988-03-18 | 1990-06-26 | Ppg Industries, Inc. | Bacteria impermeable, gas permeable package |
| US4863867A (en) * | 1988-05-18 | 1989-09-05 | Becton, Dickinson And Company | Gas permeable bio-test pack |
| US4885253A (en) * | 1989-03-27 | 1989-12-05 | Steris Corporation | Universal biological indicator system |
| US5498526A (en) * | 1993-08-25 | 1996-03-12 | Abtox, Inc. | Bacillus circulans based biological indicator for gaseous sterilants |
| EP0745138B1 (en) * | 1994-02-15 | 2001-06-06 | Minnesota Mining And Manufacturing Company | Rapid read-out biological sterilisation indicator |
-
1994
- 1994-08-18 US US08/292,737 patent/US5516648A/en not_active Expired - Lifetime
-
1995
- 1995-08-16 CA CA002197578A patent/CA2197578A1/en not_active Abandoned
- 1995-08-16 MX MX9701139A patent/MX9701139A/en unknown
- 1995-08-16 JP JP8508179A patent/JPH09510625A/en active Pending
- 1995-08-16 AU AU33284/95A patent/AU689310B2/en not_active Ceased
- 1995-08-16 EP EP95929574A patent/EP0777745A1/en not_active Ceased
- 1995-08-16 WO PCT/US1995/010443 patent/WO1996006184A1/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| EP0777745A1 (en) | 1997-06-11 |
| JPH09510625A (en) | 1997-10-28 |
| AU3328495A (en) | 1996-03-14 |
| WO1996006184A1 (en) | 1996-02-29 |
| US5516648A (en) | 1996-05-14 |
| AU689310B2 (en) | 1998-03-26 |
| MX9701139A (en) | 1997-05-31 |
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Dead |